Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)

Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1021958; Drug: BI 1021958; Drug: Placebo to BI 1021958

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1310.1.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 1021958; Single rising dose (SRD) part	Drug: BI 1021958; tablet; Drug: BI 1021958; drinking solution / tablet
Experimental: BI 1021958 (Food effect); Food effect part (FE)	Drug: BI 1021958; tablet; Drug: BI 1021958; drinking solution / tablet
Placebo Comparator: Placebo to BI 1021958; Matching placebo as drinking solution and tablets	Drug: Placebo to BI 1021958; SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with clinically relevant findings in physical examination	up to 14 days postdose
Number of participants with clinically relevant findings in vital signs	up to 14 days postdose
Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results	up to 14 days postdose
Number of participants with significant changes from baseline laboratory measurements	up to 14 days postdose
Number of participants with adverse events	up to 14 days postdose
Assessment of tolerability by investigator	up to 14 days postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum measured concentration of BI 1021958 in plasma)	up to 72h postdose
area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)	up to 72h postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)	up to 72h postdose

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 1310.1; 2011-003483-70 (EudraCT Number: EudraCT)